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Study of KBP-7072 in Healthy Male and Female Subjects

Healthy Subjects Clinical Trial

Official title:
A Phase I, Double-blind, Placebo-controlled, Single and Multiple Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study of KBP-7072 in Healthy Male and Female Subjects

Clinical Trial Summary

This is a double-blind, randomized, placebo-controlled, single and multiple IV dose study conducted in two parts. Part A (SAD) will comprise an ascending single dose, sequential group design. Each subject will participate in 1 treatment period only. Subjects will reside at the study site from check-in on Day -1 (the day before dosing) to discharge on Day 8. In Part A, serial blood and urine collections will be obtained on Day 1 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings. Part B (MAD) will comprise an ascending multiple dose, sequential group study. Each subject will participate on one treatment period only and reside at the study site from check-in on Day -1 until discharge on Day 17. In Part B, serial blood and urine collections will be obtained on Day 1 pre-dose through 24 hours post start of infusion and on Day 10 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Trough blood sample collections for analysis of plasma concentrations of KBP-7072 and KBP-6079 will be obtained pre-dose on Days 3, 4, 5, 6, 7, 8 and 9. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05507463
Study type Interventional
Source KBP Biosciences
Contact
Status Completed
Phase Phase 1
Start date August 16, 2022
Completion date June 29, 2023
View Details
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